NCT05712395 · University of Oklahoma
The Effects of a Novel, Non-ischemic and Pain-free Exercise Intervention in Peripheral Artery Disease
(NICE)
What this study is about
This study is a 3-month, forward-looking, randomly assigned controlled clinical trial designed to address the effectiveness of the Non-Ischemic Exercise (NICE) program to improve exercise and vascular outcome measures in patients with peripheral artery disease (PAD).
View original scientific description
This study is a 3-month, prospective, randomized controlled clinical trial designed to address the efficacy of the Non-Ischemic Exercise (NICE) program to improve exercise and vascular outcome measures in patients with peripheral artery disease (PAD).
Interventions
BEHAVIORAL
Exercise
Non-Ischemic Exercise (NICE), pain-free exercise program will be compared to the Standard painful exercise program.
Primary outcome measures
Peak Walking Time
Time frame: 3 months
The change in peak walking time from the pre-test value to the post-test value (seconds)
Calf Muscle Oxygen Saturation
Time frame: 3 months
The change in calf muscle oxygen saturation value during exercise from the pre-test value to the post-test value (% saturation)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- history of claudication assessed by the Walking Impairment Questionnaire,
- ambulatory leg pain in either one or both legs consistent with intermittent claudication confirmed during a screening graded treadmill test using the Gardner-Skinner protocol,
- an ABI \<= 0.90 at rest or \> 20% decrease in ankle systolic blood pressure in either one or both legs immediately following the treadmill exercise test.
- age \>= 40 years.
Exclusion criteria
- absence of PAD (ABI \> 0.90 at rest and ankle systolic blood pressure \< 20% decrease after exercise,
- inability to obtain an ABI measure due to non-compressible vessels (ABI \> 1.40),
- asymptomatic PAD (Fontaine Stage I) determined from the medical history and verified during the graded treadmill test,
- rest pain due to PAD (Fontaine stage III)
- tissue loss due to PAD (Fontaine stage IV)
- use of medications indicated for the treatment of intermittent claudication (cilostazol and pentoxifylline) initiated within three months prior to investigation,
- peripheral revascularization within one month prior to investigation, or peripheral revascularization performed during the study,
- exercise tolerance limited by any disease process other than PAD,
- active cancer,
- kidney failure defined as stage 5 chronic kidney disease,
- a calf skin fold measurement \> 25 mm, because of potential interference with the light path of the NIRS probe from penetrating the subcutaneous tissue,
- pulse arterial oxygen saturation of the index finger \< 95% because of potential deleterious effect on calf muscle StO2 from poor pulmonary gas exchange, and
- failure to complete the baseline run-in phase within three weeks.
Where
- Oklahoma City, Oklahoma
Collaborators
Case Western Reserve University, National Institute on Aging (NIA)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 29, 2026 · Source of record for eligibility and locations